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|
| General |
| Study Status |
Delayed |
Application Number /
Requirement Number |
P190009 / PAS002 |
| Date Original Protocol Accepted |
02/12/2021
|
| Date Current Protocol Accepted |
08/14/2025
|
| Study Name |
Osseointegration Quality Registry PAS
|
| Device Name |
OPRA Implant System
|
| Clinical Trial Number(s) |
NCT01725711
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
External Registry
|
| Comparison Group |
Objective Performance Criterion
|
| Analysis Type |
Analytical
|
| Study Population |
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
A multicenter, prospective, observational cohort Registry to investigate 2-year and 5-year safety and effective outcomes of the OPRATM Implant System when used for transfemoral implantation in amputee patients. The Osseointegration Quality Registry is a prospective registry sponsored by Walter Reed and conducted at all sites that consent to collect data for the registry. The registry study initiated on February 11, 2019 and is sponsored by Walter Reed. WRNMMC will provide patient level study data and results to FDA per FDA requirements and guidance and in accordance with objectives, endpoints and sample size in this protocol and will provide aggregated data bi-annual reports to Integrum AB for the OI Registry OPRA Post- Approval Study. Integrum is the sponsor of the PMA (P190009) and will provide funding to WRNMMC for data entry into OI Registry database (IQAROS) and analysis of data and is responsible for Submission of aggregated data Annual Reports and final report to FDA.
|
| Study Population |
Patients at sites that choose to take part in this investigation who have the
OPRA implant procedure and meet the eligibility criteria will be offered to
prospectively participate in the registry. The study is being offered to all US
sites that perform the OPRA implant procedure. Only OPRA patients
treated transfemorally with problems using a conventional socket prosthesis
OR patients anticipated to experience significant problems with socket use
will be included for the registry. In addition, patients from the 2-year
TFAOS study who consent to be followed long term in the registry will be included in this study.
|
| Sample Size |
85 subjects will be enrolled in the PAS registry. Up to 50 subjects will be from the other PAS study, TFAOS.
|
| Key Study Endpoints |
Endpoints Primary Endpoints:
1. Rate of overall success at 2 and 5 years. The overall success is the composite primary safety and effectiveness endpoint.
a. Primary safety endpoint: Proportion of subjects with no subsequent secondary surgical interventions and, at most, 2 superficial infections, at 2 years; and no subsequent secondary surgical interventions and at most 3 superficial infections at 5 years.
b. Primary effectiveness endpoint: Proportion of patients who achieve the minimally clinically important difference (MCID) from baseline to 2 and 5 years after the stage-2 surgery for the total Q-TFA score (mean of all subscores, i.e., prosthetic use score, prosthetic mobility score, problem score, and global score) of 20.25 points, and radiographic success, defined as no radiographic loosening of the implant with a radiolucent zone wider than the thread depth surrounding the entire implant.
2. Proportion of subjects who achieved either/or/none of primary safety endpoint or primary effectiveness endpoint at 2 and 5 years.
Secondary Endpoints:
-Proportion of subjects who achieved a significant increase in prosthetic use, individually at 2 years after the stage-2 surgery.
-Change in each of total Q-TFA score, Q-TFA prosthetic use score, prosthetic mobility score, problem score and global score from baseline to 2 and 5 years after the stage-2 surgery.
|
| Follow-up Visits and Length of Follow-up |
5 years after stage-2 surgery
|
| Interim or Final Data Summary |
| Interim Results |
No serious or unanticipated adverse events were reported during this reporting period.
The available data (preliminary results) to date demonstrate the safety and effectiveness of the OPRA device approved in the PMA.
|
| Actual Number of Patients Enrolled |
N=58, as of January 4, 2024. It is noted within this
submission that there were no more subjects enrolled
"since the previous report" at WRNMMC, however,
WRNMMC is expecting more patients to be enrolled
by the end of 2025.
|
| Actual Number of Sites Enrolled |
7 sites enrolled
|
| Study Strengths & Weaknesses |
will be included in final report
|
